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Method and limits

This site is a mechanical filter, not an analysis. Here is exactly what it does and does not do.

Where the text comes from

Every quotation is taken from the Summary of Product Characteristics (SmPC) of the product, as published on the electronic Medicines Compendium (emc) at medicines.org.uk, which carries the UK regulatory label. The link at the bottom of each product page goes to that document. Where the emc page shows a "last updated" date, that date is shown here.

How a briefing is built

  1. The manufacturer's full Summary of Product Characteristics is read, section by section, for that one product.
  2. Every statement worth knowing is written out as a single line, and tagged with the section number it comes from - composition, posology, contraindications, warnings, interactions, pregnancy, undesirable effects, pharmacology, excipients, storage.
  3. Those lines are grouped under five headings: ingredients and materials, manufacture and storage, safety findings, evidence and claims, and what the document itself concedes.
  4. Nothing is added from any other source: no other product, no news, no study that is not in the document, and no opinion about whether anything is good or bad.

A product page also carries two supporting layers, both built mechanically from the same document:

The phrase lists used for the audit trail

These do not select what goes in the briefing. They only decide which sentences are copied into the audit trail, matched as whole words.

No data / not studied

The document itself states that something was never tested, measured or established.

are unknownhas not been demonstratedhas not been evaluatedhas not been studiedhave not been establishedhave not been evaluatedhave not been studiedis unknownno datano informationno studiesnot been assessednot been characterisednot been characterizednot been determinednot been establishednot been evaluatednot been fullynot been investigatednot been studiednot known

Limited, insufficient or inconclusive

The document itself describes the evidence as limited or says a conclusion could not be reached.

could not be establishedcould not be madeinsufficientlimited availablelimited datalimited experiencelimited informationno conclusionnot possiblenot predictableremains unknownuncertainwide confidence interval

Rare or very rare serious events

Events the document lists as rare, very rare, or otherwise serious, including post-marketing reports.

acute disseminatedanaphylaarthritisbell's palsybrachialconvulsiondeathdeathsencephalfatalguillainhospitalishospitalizintussusceptionkawasakimeningitismyocardnarcolepsyreyeseizureserious adversethrombostransverse myelitisvery rare

Not recommended, contraindicated or restricted

Groups or situations the document excludes, restricts or advises against.

contraindicateddo not administerdo not useis not indicatedmust not be administeredmust not be usednot indicatednot recommendedshould be avoidedshould not be givenshould not be usedshould not receive

Animal, human or cell-line derived material

Substances sourced from animals, humans or continuous cell lines, as stated in the document.

abortedalbuminbaculovirusbloodbovinecalfcalvescaseinchickene. colieggfetalfoetalhamsterhenhenshuman albuminhuman seruminsectlactalbuminmonkeypigplasmaporcinesimiantobaccoveroyeast

Trace residues and process chemicals

Residues the document states may remain in the finished product.

2-phenoxyethanolantibioticbenzonasecetyltrimethylammoniumdeoxycholateformaldehydegentamicinglutaraldehydehost cellkanamycinmercuryneomycinovalbuminphenolpolymyxinpolysorbateresiduestreptomycinthimerosalthiomersaltracetriton

Adjuvants, carriers and immune-stimulating ingredients

Ingredients included to provoke or steer an immune response.

adjuvantaluminiumaluminumas01as03as04carrier proteincpgcrm197emulsionlipid nanoparticlemonophosphorylnanoparticleqs-21saponinsqualenetocopherol

Genetic engineering, vectors and GMOs

Where the document states genetic modification, recombinant technology or a viral vector is used.

attenuatedcell-derivedchimericdnagenetically modifiedgmolivemrnaplasmidrecombinantreverse geneticvector

Immune system, shedding and transmission

Statements about immune suppression, viral shedding or transmission to other people.

autoimmuneimmune deficiencyimmune-mediatedimmunocompromisedimmunosuppressreyeshedsheddedsheddingtransmissiontransmit

Efficacy, effectiveness and endpoints

Statements about whether and how well the product works, including surrogate endpoints and confidence intervals.

confidence intervalcorrelate of protectioneffectivenessefficacygeometric meanimmune responsenon-inferiornoninferiorseroconversionsuperiorsurrogate

What is theirs and what is ours

The three layers are kept visually separate, and it matters which is which.

What this site does not do

Real limits of this method

Corrections

If a quotation here does not match the source document, it is a fault and should be treated as one. Regenerated from the source documents.